BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 6269746 · Received January 23, 2017

    Report

    Report Number
    2520274-2017-10226
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    December 27, 2016
    Report Date
    December 27, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT A TWO PART FRACTURE OF THE RIGHT PROXIMAL HUMERUS. BEFORE THE ACTUAL DRILLING, SURGEON PERFORMED THE INTERFERENCE TEST IN DRY CONDITION. BY USING AN AIMING ARM, SURGEON CONFIRMED THAT THE PROTECTION SLEEVE, DRILL SLEEVE, TROCAR, AND DRILL BIT FUNCTIONED PROPERLY WITH THE SHORT MULTILOC PROXIMAL HUMERAL NAIL (PHN). THE DRILL BIT COULD PASS THROUGH THE PHN. AFTER INSERTING THE SHORT PHN, SURGEON TRIED THE DISTAL SIDE STOPPAGE WITH ¿F HOLE¿. HOWEVER, THE DRILL BIT INTERFERED WITH THE PHN. SURGEON PROCEEDED WITH THE SIDE STOPPAGE WITH THE MOST DISTAL ¿G HOLE¿ AND COMPLETED THE DRILLING. IT IS UNKNOWN HOW MANY HOLES THE SURGEON USED FOR THE SIDE STOPPAGE. SURGEON COULD NOT COMPLETE ¿F HOLE¿ SIDE STOPPAGE WITH THE DRILL BIT, SURGEON COMPLETED THE SIDE STOPPAGE WITHOUT USING ¿F HOLE¿. THERE WAS A 30 MINUTES SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND IF ANY MEDICAL INTERVENTION WAS REQUIRED. PATIENT STATUS/OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: AIMING ARM (PART: 03.019.008, LOT: UNKNOWN, QUANTITY: 1), PROTECTION SLEEVE (PART UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), DRILL SLEEVE (PART UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TROCAR (PART UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS IS REPORT NUMBER 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53202 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION BIT, DRILL HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 1 X AIMING ARM (PART# 03.019.008)| 1 X DRILL SLEEVE (PART# UNKNOWN)| 1 X PROTECTION SLEEVE (PART# UNKNOWN)| 1 X TROCAR (PART# UNKNOWN)